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Clinical Trials/NCT04269798
NCT04269798
Completed
N/A

The Effect of Functional Electrical Stimulation Technology on Gait and Balance Performance in Children With Hemiplegic Cerebral Palsy

Umm Al-Qura University1 site in 1 country40 target enrollmentFebruary 11, 2020
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Umm Al-Qura University
Enrollment
40
Locations
1
Primary Endpoint
Change from baseline spatial and temporal gait analysis at 3 months
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The aim of this study will be to evaluate the effect of FES on stimulation of the anterior tibial group by using the WalkAide foot drop stimulator on improving walking and balance abilities in children with hemiplegic CP.

Detailed Description

The aim of this study will be to evaluate the effect of FES on improving walking and balance abilities in children with hemiplegic CP. Forty children with hemiplegic CP will be assigned randomly into two groups (A \& B). Control group (A) will receive conventional rehabilitation program for lower limb, balance and gait training. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to FES by using the WalkAide foot drop stimulator. Patients' evaluation will be carried out before and after training to assess walking ability and balance performance.

Registry
clinicaltrials.gov
Start Date
February 11, 2020
End Date
April 15, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Shamekh Mohamed El-Shamy

Professor

Umm Al-Qura University

Eligibility Criteria

Inclusion Criteria

  • Their weight should be less than 40 kg.
  • The spasticity degrees of the affected lower limb will range between grades (1, 1+ \& 2) according to Modified Ashworth Scale (MAS).
  • Those children functioning scores at Gross Motor Function Classification System (GMFCS) Levels I and II.
  • They can walk 10 min conditionally without an orthosis.
  • Ought to be intellectually skilled and ready to comprehend and take after directions.
  • They will have neither serious nor recurring medical complications.
  • Children's height will be more than 100 cm to fit with the Biodex balance equipment that will be used in this study to evaluate balance performance.
  • No serious hip \& knee flexion tightness will be present. Knee flexion at starting contact should be between 20-40º .
  • Peroneal nerve and the proximal leg muscles ought to be in place.
  • They ought to have no significant issues influencing balance other than spasticity.

Exclusion Criteria

  • Children who demonstrate skin diseases or allergic reactions to adhesive tape or any other materials used in this study.
  • Children with visual, auditory or perceptual deficits.
  • Children with surgical interference for the lower limb.
  • Children with seizures or epilepsy.
  • Children who received botulinum toxin in the lower extremity musculature during the past 6 months or who wish to receive it within the period of study, other spasticity medication within 3 months of pre-treatment testing .
  • Children with pacemakers or other diseases that are contraindicated by electrical stimulation.

Outcomes

Primary Outcomes

Change from baseline spatial and temporal gait analysis at 3 months

Time Frame: Baseline and 3 months post-intervention

Spatial and temporal gait analysis will be evaluated for every child at baseline and 3 months post-intervention using the Noraxon's Myo PRESSURE plate.

Change from baseline postural stability at 3 months

Time Frame: Baseline and 3 months post-intervention

Postural stability will be evaluated at baseline and 3 months post-intervention using the Biodex Balance System (BBS) (Balance System SD, Shirely, NY, USA).

Study Sites (1)

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